BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 16262121 · Received January 29, 2023

    Report

    Report Number
    1119779-2023-00086
    Event Type
    Malfunction
    Date Received
    January 29, 2023
    Date of Event
    January 11, 2023
    Report Date
    March 31, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 2212158. IT WAS REPORTED THAT THE CUSTOMER GETTING FALSE POSITIVES FOR FLU A FROM THE BD VERITOR¿ SARS-COV-2 AND FLU A+B KIT. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BASED ON THE AVAILABLE INFORMATION UNDERSTOOD THAT CUSTOMER HAD RECEIVED FALSE POSITIVE RESULT FOR FLU A FROM BD VERITOR, HOWEVER CUSTOMER HAD PERFORMED ALTERNATIVE TEST (ABBOT ID NOW) RESULTED NEGATIVE RESULTS FOR FLU A. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUE WAS FOUND. SAMPLE WERE RETURNED FOR ANALYSIS AND RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR FALSE POSITIVE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    REPORT 3 OF 3. IT WAS REPORTED BD VERITOR ¿ SARS-COV-2 & FLU A+B RECEIVED POSITIVE RESULT BUT WAS RE RUN ON SEPARATE TEST AND NEGATIVE RESULT OCCURRED. NO INJURIES OR TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES VISUALLY SEE ADDITIONAL LINE BELOW FLU A. CARTRIDGE RUN ON VERITOR AND FLU A POSITIVE. NO ERRORS. QC PERFORMED. SAMPLES RECOLLECTED AND SAME ADDITIONAL LINE SEEN VISUALLY. FLU A POS ON REPEATS.

    Description of Event or Problem · 0

    REPORT 3 OF 3 IT WAS REPORTED BD VERITOR ¿ SARS-COV-2 & FLU A+B RECEIVED POSITIVE RESULT BUT WAS RE RUN ON SEPARATE TEST AND NEGATIVE RESULT OCCURRED. NO INJURIES OR TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES VISUALLY SEE ADDITIONAL LINE BELOW FLU A. CARTRIDGE RUN ON VERITOR AND FLU A POSITIVE. NO ERRORS. QC PERFORMED. SAMPLES RECOLLECTED AND SAME ADDITIONAL LINE SEEN VISUALLY. FLU A POS ON REPEATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BECTON, DICKINSON & CO. (SPARKS) 2212158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown